EP2704672B1 - Dispositif de protection d'hémorroïdes - Google Patents

Dispositif de protection d'hémorroïdes Download PDF

Info

Publication number
EP2704672B1
EP2704672B1 EP12779337.0A EP12779337A EP2704672B1 EP 2704672 B1 EP2704672 B1 EP 2704672B1 EP 12779337 A EP12779337 A EP 12779337A EP 2704672 B1 EP2704672 B1 EP 2704672B1
Authority
EP
European Patent Office
Prior art keywords
balloon
anal canal
hemorrhoids
anchoring
rectum
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP12779337.0A
Other languages
German (de)
English (en)
Other versions
EP2704672A1 (fr
EP2704672A4 (fr
Inventor
Ran Carmeli
Moshe Klaiman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Relief Therapies Inc
Original Assignee
Relief Therapies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Relief Therapies Inc filed Critical Relief Therapies Inc
Publication of EP2704672A1 publication Critical patent/EP2704672A1/fr
Publication of EP2704672A4 publication Critical patent/EP2704672A4/fr
Application granted granted Critical
Publication of EP2704672B1 publication Critical patent/EP2704672B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0093—Rectal devices, e.g. for the treatment of haemorrhoids

Definitions

  • the present invention relates to a device for protecting hemorrhoids during defecation and more specifically to an anal canal-positioned device that biases internal hemorrhoids against the canal wall and thus prevents swelling and/or prolapse and/or irritation of internal and optionally external hemorrhoids caused by physical straining and/or defecation.
  • US 3,826,242 A represents the closest prior art.
  • Hemorrhoids are anal canal wall structures which are composed of arterio-venous channels and connective tissue and serve as cushions to aid the passage of stool.
  • Hemorrhoids become pathological when swollen or inflamed; pathological hemorrhoids are often referred to as piles. The symptoms of pathological hemorrhoids depend on hemorrhoid type. Internal hemorrhoids typically present as painless rectal bleeding while external hemorrhoids present with pain in the area of the anus.
  • External hemorrhoids occur at the distal end of the anal canal near the anal orifice. External hemorrhoids are varicosities of the veins draining the inferior rectal arteries, which are branches of the internal pudendal artery. They are sometimes painful, and often accompanied by swelling and irritation. Itching, although often thought to be a symptom of external hemorrhoids, is more commonly due to skin irritation. External hemorrhoids are prone to thrombosis: if the vein ruptures and/or a blood clot develops, the hemorrhoid becomes a thrombosed hemorrhoid.
  • Internal hemorrhoids occur in the dentate line, which is the anatomical landmark at the boundary between the anal canal to the rectum, and are varicosities of veins draining the superior rectal arteries. Since this region lacks pain receptors, internal hemorrhoids are usually not painful, however, they may bleed when irritated and or swollen. Untreated internal hemorrhoids can lead to two severe forms of hemorrhoids: prolapsed and strangulated hemorrhoids. Prolapsed hemorrhoids are internal hemorrhoids that are distended and pushed outside the anus.
  • anal sphincter muscle goes into spasm and traps a prolapsed hemorrhoid outside the anal opening, the supply of blood is cut off, and the hemorrhoid becomes a strangulated hemorrhoid.
  • hemorrhoids One main cause of prolapsed hemorrhoids is straining, caused by, for example, defecation.
  • defecation For people who suffer from hemorrhoids, defecation, resulting in hemorrhoids prolapse, is not only painful, but a daily trigger to the progression of the disease. Defecation may also lead to bleeding of hemorrhoids, due to contact between fecal matter and hemorrhoidal tissue.
  • Hemorrhoid treatment typically involves an increase in fiber intake, oral fluids to maintain hydration, NSAID analgesics, sitz baths, and rest. Surgery is reserved for cases that fail to improve following such treatment.
  • a device for reducing pain, bleeding and/or distension of hemorrhoids during defecation and optionally straining comprising a balloon configured for anchoring within a lower rectum of a subject when inflated, the balloon being attached to a tubular mesh structure being substantially non-elastic along a longitudinal axis and elastic along a radial axis thereof.
  • the tubular mesh structure is adapted to extend from the lower rectum and into an anal canal when the balloon is inflated and anchored in the lower rectum.
  • tubular mesh structure is coated with silicone.
  • tubular mesh structure is fabricated from polyester or nylon.
  • tubular mesh structure is fabricated from a metallic material selected from the group consisting of stainless steel, nitinol, and cobalt chromium.
  • the balloon is a toroidal balloon.
  • the toroidal balloon includes a conically shaped opening.
  • the balloon is a non-compliant balloon.
  • the device further comprises a tubular sheath for radially constraining the tubular mesh structure in a folded configuration.
  • the tubular sheath includes a mechanism for releasing the tubular mesh structure from the folded configuration.
  • the mechanism tears the sheath.
  • the mechanism removes the sheath.
  • the balloon is inflated to at least 2 ATM.
  • a system for reducing pain, bleeding and/or distension of hemorrhoids during defecation comprising the device described herein and an applicator for positioning and deploying the device in an anal canal-rectum region of a subject.
  • the applicator disengages from the device upon inflation of the balloon. Such disengagement can be effected via controlled ripping of the applicator.
  • the present invention successfully addresses the shortcomings of the presently known configurations by providing a device capable of shielding hemorrhoids from swelling by applying a counter pressure on the hemorrhoids, and by shielding the friction exerted by stool during defecation while being easily applicable without causing discomfort during application and use.
  • the present invention is of a device which can be used to prevent progression of internal hemorrhoids as well as reduce or prevent bleeding or pain associated therewith.
  • U.S. Pat. No. 3,826,242 describes a tubular member that is inserted into the anal canal/rectum in order to serve as a hemorrhoidal barrier during defecation.
  • the tubular member is maintained in the anal canal via a support that engages the toilet seat or via inflatable walls that exert pressure on anal canal tissue and a flared region that engages tissue around the rectal opening.
  • U.S. Pat. No. 1,527,068 describes a simple tubular member that is postionable via an insert member in the anal canal/rectum and is used to protect the hemorrhoids during bowel movement.
  • the present inventors While reducing the present invention to practice, the present inventors have carefully studied the anatomy and function of the anal canal and rectum and have devised a hemorrhoid-shield device which is capable of protecting hemorrhoids from distension, bleeding and pain during defecation and yet is easily deployable and does not cause discomfort during use.
  • a device for preventing hemorrhoidal prolapse during straining as well as protecting hemorrhoids from prolapse during straining and for preventing/reducing the mechanical pressure on hemorrhoids caused by passage of stool for preventing hemorrhoidal prolapse during straining as well as protecting hemorrhoids from prolapse during straining and for preventing/reducing the mechanical pressure on hemorrhoids caused by passage of stool.
  • the present device includes at least one anchor portion which is positionable above and/or below the anal canal (e.g. in the rectum above the dentate line and/or outside the anal orifice, see Figure 2a ) and a tubular portion (e.g. sleeve) that covers the internal and optionally external hemorrhoids and forcibly biases them against the canal wall (radially).
  • anal canal e.g. in the rectum above the dentate line and/or outside the anal orifice, see Figure 2a
  • a tubular portion e.g. sleeve
  • FIGS. 2-9b illustrate several embodiments of the present device which is referred to herein as device 10.
  • Figures 2a-e illustrate an embodiment of device 10 which includes one or more inflatable chambers forming anchor portion(s) 12 and a sleeve portion 14.
  • Sleeve 14 is generally biased against the anal canal and / or hemorrhoids, and may optionally include support and/or biasing struts 38 or one or more inflatable chamber(s) to facilitate biasing.
  • struts 38 provide sleeve 14 of device 10 with longitudinal support which assists in anchoring as is further described hereinbelow.
  • Figure 2a is a cross section of Device 10 in a deployed state and positioned spanning a portion of the rectum and the anal canal.
  • distal portion 18 of device 10 resides above the rectal neck, preferably above the dentate line ( Figure 1 ), while proximal portion 20 resides outside the anal canal and is in contact with tissue surrounding the anal orifice (e.g. skin surrounding anal orifice).
  • Sleeve portion 14 spans the anal canal and is attached between anchor portions 12.
  • Figure 2a illustrates a presently preferred configuration of device 10 which includes two anchor portions 12 interconnected by sleeve 14; anchor portions 12 are configured as a distal anchoring balloon 26 and a proximal anchoring balloon 28.
  • Sleeve 14 can extend beyond anchor portions 12 to form proximal skirt 31 and distal skirt 33.
  • Distal anchoring balloon 26 and proximal anchoring balloon 28 can be filled through one or more lumen(s) 27 (one shown) capable of communicating fluid such as air, gas, water or saline to distal anchoring balloon 26 and proximal anchoring balloon 28 from one or more filling port (s) 29 (one shown) positioned at a proximal portion 20 of device 10.
  • lumen(s) 27 one shown
  • fluid such as air, gas, water or saline
  • distal anchoring balloon 26 is configured for applying a radial (outward) force against rectal wall tissue (mucosa) when expanded.
  • distal anchoring balloon 26 is designed to accommodate for such expansion and maintain anchoring.
  • Figures 2b-c illustrate one configuration of distal anchoring balloon 26 which is capable of maintaining anchoring when the rectum and anal canal are collapsed (devoid of fecal matter) and when they are distended by fecal matter.
  • Distal anchoring balloon 26 and/or proximal anchoring balloon 28 are shaped as a toroidal balloon ( Figure 2b ) which is capable of elastically deforming and opening.
  • the toroidal balloon is formed from a discontinuous balloon (e.g. C-shaped) as shown in 2b and 2c.
  • Gap 30 in distal anchoring balloon 26 can be unoccupied or it can include an elastic element 32 (as shown in Figures 2b-c ) which is attached to ends 34 of the discontinuous toroidal balloon.
  • an elastic element 32 elastically stretches when fecal matter transits through opening 36 and thereby maintains sealing of distal anchoring balloon 26 against rectal mucosa.
  • Element 32 can alternatively be an elastic biasing element (spring) that biases ends 34 outwardly and thus opens gap 30 and maintains distal anchoring balloon 26 biased against rectum when the rectum increases in diameter (to accommodate for fecal matter movement therethrough).
  • distal anchoring balloon 26 of Figures 2a-c is formed from a single (gapped) expandable chamber, other configurations including two or more (gapped) chambers optionally interconnected via elastic or sprung elements are also envisaged herein.
  • distal anchoring balloon 26 can be formed from a toroidal balloon including 1, 2, 3, 4, 5 or 6 separate chambers.
  • distal anchoring balloon 26 and proximal anchoring balloon 28 are surrounded by skirt 33 and skirt 31 (respectively).
  • Skirts 31 and 33 extend beyond the regions of balloon anchoring to provide additional anchoring forces (frictional) and to improve the sealing against the rectal mucosa (at distal portion 18 of device 10) and against the skin outside the anal orifice (at proximal portion 20 of device 10). Skirts 31 and 33 are further described hereinbelow.
  • Anchoring can alternatively be achieved by placing a (continuous) toroidal balloon in a region of the rectum which is capable of accommodation, e.g. where the wall tissue is pliable and capable of accommodating a large diameter balloon.
  • the diameter of such a balloon (when inflated) will be selected larger than the typical maximum diameter of the anal canal during defecation (e.g. about 40 mm). Additional anchoring and longitudinal integrity provided to device 10 by sleeve 14 fitted with struts 38 will prevent balloon 26 from "flipping" and being pushed out during defecation.
  • Anchoring is maintained by matching the pressure of balloon 26 with defecation pressure inside the rectum [typically 0.5-4 atmospheres (atm)].
  • Skirt 33 will be forced against the rectal wall by fecal matter during defecation/constipation providing an additional anchoring force.
  • pressure applied to skirt 33 by balloon 26 will force skirt 33 to firmly adhere to the rectal wall tissue.
  • Anchoring can also be enhanced by varying the surface texture and frictional coefficient of the inner (facing feces) and outer (facing GI tissue) surfaces of device 10.
  • Inner surfaces which come in contact with fecal matter are preferably coated/formed to provide low friction forces (e.g. by using a Teflon based materials), while the outer surfaces which come in contact with rectal and anal canal tissue are coated/formed to provide high frictional forces (e.g. by using silicon based materials).
  • Figures 2d-e illustrate alternative cross sectional shapes for anchoring balloons 47 and 48.
  • Figure 2e illustrates an alternative skirt 49 configuration.
  • Balloons 26 and 28 can be fabricated from compliant materials (e.g. polyurethane and/or silicon); semi compliant materials (e.g. nylon resin and/or PEBAX) or non compliant materials (PET) or any combinations thereof.
  • the balloons can be fabricated using blow-molding, extrusion or thermal bonding approaches.
  • Balloons 26 and 28 can have an external diameter in the range of 30-60 mm, an internal diameter of 20-55 mm and a cross section diameter (e.g. height) of 2 - 10 mm. Inflation pressure of such balloons depends on the material and production approaches used. For example, a complainant balloon anchor (e.g.
  • silicon/polyurethane can be inflated to a pressure of 1 - 5 atmospheres, while semi-compliant or non-compliant balloon anchors can be inflated to 20 atmospheres.
  • a typical inflation pressure for balloon 20 and 26 can be in the range of 1-5 atm.
  • Proximal anchoring balloon 28 can be configured similarly to distal balloon, but since it is positioned outside the anal canal it can be formed from a continuous toroidal balloon with an opening 36 having an external diameter of 30-60 mm and an internal diameter of 20-55 mm.
  • proximal anchor portion is presently preferred, other forms of anchors using spring type materials, adhesives tapes and the like can also be used in the proximal anchoring portion of device 10.
  • Sleeve 14 can be fabricated from materials similar or identical to those described above. Preferred materials include semi-compliant silicon and polyurethane. Sleeve 14 can be produced via extrusion, molding and the like. Sleeve 14 can be bonded to balloons 26 and 28 (e.g. using thermal bonding/welding or adhesives). Sleeve 14 is typically 20 - 60 mm in length with a diameter of about 30 mm when pushed open (e.g. by feces) and 2-16 mm when collapsed.
  • sleeve 14 can optionally include struts 38.
  • Struts 38 run along the length of sleeve 14 (i.e. along a longitudinal axis thereof) and as such provide longitudinal integrity and column strength to the sleeve 14.
  • Struts 38 provide sleeve 14 with flexibility in the radial direction and thus enables it to easily comply with the anatomy during defecation.
  • the number of struts 38 varies with a range of 4 - 16.
  • Struts 38 can be evenly or non-evenly distributed around a circumference of sleeve 14 and can be optionally radially connected with flexible connecting members that do not limit the radial compliancy of the sleeve.
  • Struts 38 can be fabricated from a material that provides the longitudinal rigidity necessary to prevent inversion of sleeve 14 and balloon 26. Exemplary materials include stainless steel, Nitinol, polymers and the like.
  • the struts can be fabricated having a round or square cross sectional shape with a diameter of typically 0.3 to 2 mm.
  • Struts 38 can be embedded within the material of sleeve 14 (e.g. sleeve 14 can be overmolded onto struts 38), or attached on an external and / or internal surfaces of sleeve 14.
  • Struts 38 are designed such that upon expansion of upper and lower anchoring regions of device 10 (e.g.
  • struts 38 ends of struts 38 remain secured to balloons 20 and 26 while the mid-portions of struts 38 flex about 1 - 10 mm toward the anal canal tissue. This ensures that struts 38 effectively bias sleeve 14 against anal canal walls in general and against the hemorrhoids in particular.
  • Sleeve can alternatively or additional include one or more inflatable chambers (not shown) which can provide sleeve 14 with the additional rigidity and shape necessary to apply the biasing force to the hemorrhoids.
  • Figures 3a and 3b illustrate a device 10 in which sleeve 14 includes inflatable member 62 which is connected between a distal anchoring balloon 52 and a proximal anchoring balloon 54. Such configuration can improve the biasing on the anal canal. Addition of struts 58 can also improve device 10 integrity (in the longitudinal axis) as well as increase biasing of sleeve 14 against anal canal tissue.
  • Figure 3b illustrates an upper skirt 56.
  • the central inflatable section 62 may be inflated by a fluid such as water and / or air or it can self inflate upon wetting by the mucosa.
  • Figure 3c illustrates a similar device 10, in which sleeve 14 includes several radially-disposed inflatable members 66 longitudinally spaced between the anchoring balloons. Such segmented inflatable members 66 can enhance the compliance to anal canal anatomy and biasing against hemorrhoids of device 10.
  • Figure 4 illustrates another embodiment of device 10 which includes an elastic wire/strut structure covered with a membrane.
  • Such devices can be manufactured by an elastic and/or super elastic alloys or polymers such as Nitinol, Stainless Steel, Nylon etc...Sizes and shape are designed to provide the radial forces distribution along the device axis.
  • the upper portion of the device 40 will be expanded to a diameter of 30 - 60 mm, while the central portion of the device will be biased against the anal canal covering a typical range of 2 - 30 mm.
  • Mesh structure includes anchor portions 14 which in this case are formed as distal coil 40 and proximal coil 42. Coils 40 and 42 extend from ends of a wire tube structure 44 which when covered with a membrane, forms sleeve 14.
  • the cross section of the wire used to fabricate the device can be in many shape, typically it will be round having a diameter of 0.05 - 1 mm. Fabrication of the device can be effected via braiding. Alternatively, other mechanical methods can be used for fabrication of the device, such as laser cut of a tubular member.
  • Figure 5a illustrates deployment of device 10 using an applicator 50.
  • deployment of device 10 (as shown in steps I-VI of Figure 5a ) is illustrated with respects to line boundaries defining the rectum and anus illustrated in Figure 5b .
  • Device 10 is radially folded within an external applicator 50, having an external diameter of about 5 - 12 mm.
  • Device 10 is advanced in its compressed state through the anus and into position (I-VI).
  • Applicator 50 is then pulled out and device 10 expands in position.
  • the anchoring of the device into its position, in its expanded mode, is achieved due to pressure applied to the upper skirt of the device 43.
  • the distal/upper portion of the device collapses, thereby enabling easy extraction of the device following defecation.
  • Figures 6a - 6d illustrate a device 10 that is activated via mechanical pulling of an inner structure 74.
  • Device 10 includes an outer (mesh) structure 72 which is supported over an inner sleeve 74.
  • outer structure 72 compresses and collapses downward as shown in Figures 6b-d , thereby deploying anchor regions 76 and 82 each having a typical cross section 78 and 80 respectively.
  • Outer structure 72 can be covered with an elastic sleeve (e.g. silicone or Teflon based material) for comfort.
  • an elastic sleeve e.g. silicone or Teflon based material
  • sleeve 74 When device 10 is in a pre-deployed mode, i.e. stretched and elongated over sleeve 74, it sized and configured (diameter of 5 - 12 mm) capable of insertion into the anal canal. Once positioned in the anal canal/rectum ( Figure 6a ), inner sleeve 74 can be pulled out ( Figures 6b-c ) to collapse outer structure 72 and anchor device 10 in position ( Figure 6d ). Outer structures 72, 76 and 82 can be fabricated from braided/laser cut elastic material such as Nitinol, stainless steel or polyester.
  • outer structure can be further strengthened by using longitudinal struts (not shown) similar to those described above with respect to Figures 2-3 ).
  • Figure 7a - 7e illustrate another embodiment of device 10 which employs a mechanical activation structure.
  • This embodiment of device 10 includes a mechanical fixture that converts a longitudinal pulling force (in the proximal direction) into radial expansion.
  • Figure 7a illustrates a cross section of device 10, while Figure 7b illustrated a 3D model cut out.
  • the basic mechanical structure includes 2 sections: an internal activating unit 94 which is housed within an external folding unit 92.
  • Unit 94 can include a stopper at end 98 which can be positioned against the external surface of the anal orifice.
  • Device 10 can include 4 - 12 mechanical structures which are radially distributed (evenly or not evenly) within sleeve 90.
  • Sleeve 90 may include an additional spring-like coil (not shown) that provides a radial expansion force and ensure that the mechanical structures are radially pushed out and are biased against anal canal tissue.
  • the present device can be used to protect internal and optionally external hemorrhoids from the deleterious effects of physical straining and/or defecation and thus prevent swelling and/or prolapse and/or irritation of internal and optionally external hemorrhoids caused thereby.
  • the present device is inserted in its collapsed state into the anal canal ( Figure 8a ). In its collapsed state, the device is typically 4 - 12 mm in diameter.
  • Devices which include a mechanical support do not need an applicator.
  • a mechanical support e.g. longitudinal struts
  • Such a device is inserted to the anal canal thru the anus, and advanced to position.
  • the device can optionally include a ring at the proximal end that serves as a stop against the external surface of the anal orifice.
  • Devices which do include struts or do not inherently have mechanical rigidity in the longitudinal axis, utilize an internal or external applicator.
  • an applicator provides the device with the longitudinal rigidity necessary for pushing the device into position.
  • An applicator can be a rod onto which the device is fitted, or a cover which wraps the device.
  • distal and proximal anchors e.g. balloon 26 and 20 of Figures 2a-c
  • Figure 8b a pump which is connected to port 29 of device 10 shown in Figures 2a-c .
  • the pump delivers a fluid (e.g. air, saline, water) to a final which does not cause discomfort to the user.
  • a fluid e.g. air, saline, water
  • the pressure applied by the device ensures that it is securely biased against the anal canal and rectum walls at a pressure level equal to the pressure delivered by the pump.
  • the pressure delivered by the pump is determined as follows:
  • the pump is switched off or reversed and the fluid is drained from the device causing the device to collapse thus enabling removal and disposal by the user.
  • Device 10 of Figures 7a-e can be packed into an external applicator (not shown) having an external diameter of 5 - 16 mm.
  • the packed system (device + applicator) is then positioned within the anal canal and rectum with stop 98 resting against.
  • Unit 94 is then pulled out ( Figures 7c, 7d and 7e ) until unit 92 is deployed and sleeve 90 is biased against the anal canal.
  • a lock 93 may be used to lock deployed unit(s) 92 in position.
  • device 10 conforms to the anatomy while providing a biasing force against the anal canal and thereby shielding the hemorrhoids.
  • units 94 are pushed back in (distally) to unfold units 92 and enable removal of device 10 by the user.
  • Figures 8a-b illustrate anal delivery and deployment of one embodiment of the present device.
  • the device in its folded form, is inserted into the anal canal, such that the distal end of the device protrudes into the lower rectum ( Figure 8a ).
  • the device is then expanded (via any of the mechanisms described herein) to form the distal and proximal anchoring portions (dashed lines) which anchor the device within the anal canal and rectum.
  • Device 100 includes a tubular body 102 (having a round or oval cross section) having flanged proximal and distal ends (104 and 106 respectively).
  • Distal end 106 includes a balloon 108 which is constructed from a semi or non-compliant material such as nylon, silicon, Teflon or other applicable materials.
  • Balloon 108 is an open or preferably closed toroidal balloon which encompasses most or preferably all of the circumference of tubular body 102.
  • Balloon 108 can be glued/sutured to distal end 106 of tubular body 102 or alternatively, balloon 108 can include an integrated skirt 109 which is attached to tubular body via an adhesive, sutures and the like.
  • Tubular body 102 is preferably constructed from a polymeric mesh (e.g. polyester), using approaches well known in the art such as braiding, casting, or the like.
  • the braided tube is then a heat treated to provide the tubular body with its final shape.
  • the mesh structure of tubular body 102 is preferably coated (e.g. laminated) with a soft polymeric material such as silicone or teflon in order to increase comfort.
  • a soft polymeric material such as silicone or teflon
  • Such coating can also be used to lock or partially lock the junctions of the braid and hence increase the radial force of the braid while maintaining its flexibility.
  • the junctions (all or portion) can be heat welded or glued.
  • the internal surface of tubular body 102 can be coated with a low friction material such as Teflon embedded coating to facilitate passage of feces therethrough.
  • the coated mesh of tubular body 102 defines a lumen 110 (passageway) extending from an opening 112 at distal end 106 (defined by balloon 108) to an opening 114 at proximal end 104.
  • Lumen 110 is sized and configured for passage of feces therethrough when device 100 is anchored within the anal canal and rectum.
  • tubular body 102 exhibits longitudinal integrity and radial compliance (preferably elastic). Radial compliance of tubular body 102 is preferably in the range of 10- 40 mm of deflection per a pressure that is equivalent to 20 - 200 mmHg. Typical dimensions of device 100 are shown in Figure 9b .
  • Device 100 is positionable and anchorable within the anal canal and bottom region of the rectum (region of transition from rectum to anal canal also referred to herein as the rectal neck). Anchoring of device 100 is effected via two mechanisms:
  • device 100 is used for treating disorders of the anal canal and rectum, it is preferably configured to facilitate passage of feces through lumen 110 while remaining anchored in position.
  • balloon 108 is shaped such that opening 112 is conical, i.e. it tapers in the proximal direction. Such a conical opening is preferably achieved by angling balloon 108 as shown in Figure 9b .
  • Such tapering ensures that feces entering through opening 112 applies an outward radial force on balloon 108 further pushing it against the rectal walls thereby increasing the anchoring force which is determined by the pressure applied on the balloon and hence on the rectum walls, and the angle of the conical balloon.
  • Such tapering also ensures that feces transitions into lumen 110 is smoother, and unobstructed.
  • Figures 9c-d illustrate a device 100 which is similar in construction to device 100 shown in Figures 9a-b with the exception that balloon 108 is flatter and not conical in shape.
  • balloon 108 is toroidal in shape and conforms to the bottom of the rectal neck region, rather than the sides as is the case with device 100 of Figures 9a-b .
  • Device 100 can be delivered into the anal canal/rectum using a delivery device (applicator).
  • Device 100 can be folded and compressed into the delivery device or it can be wrapped by a thin sheath which can be torn to deploy the device using a tear string, balloon inflation and the like.
  • the applicator can be manually slid off the device prior to, or following inflation of the balloon anchor.
  • the radial force generated by inflation of the balloon anchor of the device can rip the applicator and allow its release or push the applicator downward to facilitate release.
  • a prototype of device 100 ( Figure 14 ) constructed in accordance with the teachings of the present was tested in animal models. As is described in Example 3 of the Examples section which follows, this prototype firmly anchored in the animal rectum with the tubular body biased against anal canal walls. Defecation through the device was achieved without device movement, the animal did not show any signs of stress or discomfort.
  • the external surface of the present device can be coated with a powder, ointment or gel containing a drug such as a topical anesthetic (e.g., benzocaine), a topical steroid (e.g., hydrocortisone) or a topical vasoconstrictor (e.g., ephedrine sulfate) using approaches well known in the art.
  • a topical anesthetic e.g., benzocaine
  • a topical steroid e.g., hydrocortisone
  • a topical vasoconstrictor e.g., ephedrine sulfate
  • Prototypes based on a tubular mesh and/or balloon anchor were developed and tested for several parameters including flexibility (minimum and maximum folding/ expanding diameter), biasing force, anchoring via pulling force out of an In-Vitro gig (that simulate the anal canal).
  • Figure 10 illustrates a tubular mesh prototype constructed from a polyester material, formed by a braiding machine.
  • the tubular mesh was configured as an hourglass with the openings being 45-50 mm in diameter, the neck being 45 mm long and the opening in the middle of the neck being 25-30 mm in diameter.
  • the mesh struts were configured to provide minimal compressibility and elongation in the longitudinal axis while maximizing compression and elasticity along the radial axis. To do so, the angle of the mesh was calculated, and few models each with other angle were produced. The effect of the angel was measured including the flexibility and biasing.
  • the prototype exhibited longitudinal stiffness and radial elasticity under a force equivalent to a radial pressure of 20-100 mmHg.
  • Figure 11 illustrates a balloon-based device which includes two anchoring balloons flanking a tube.
  • This prototype was fabricated from nylon with the following dimensions: overall length: 76 mm, diameter of tube: 35 mm, diameter of balloons 55 mm. A tube for inflating the balloons was attached to device.
  • Prototypes combining struts ( Figure 12a ) or mesh ( Figure 12b ) for vertical support and radial compliance and a balloon anchor were designed and tested in vitro.
  • Each of the prototypes (strut-balloon or mesh-balloon) was loaded into the apparatus and anchored by inflating the balloon(s) to approximately 1 ATM.
  • the apparatus was held steady and the prototype was pulled longitudinally via a force measurement system at a pulling force of approximately 1000 grams.
  • each of the prototypes was tested for radial elasticity and the ability to conform to the anal canal anatomy.
  • test apparatus ( Figures 13a-b ) simulating the anatomy of an anal canal was constructed and used to test anatomical conformation and anchoring.
  • the test apparatus included an inflatable balloon which enables radial closing and opening of the lumen of the apparatus.
  • the prototypes were inserted into the apparatus which was inflated to transition from a lumen opening diameter of 30 mm ( Figure 13b ) to a completely closed lumen ( Figure 13a ). Visual inspection of the prototypes in the testing apparatus enabled determination of device conformity and elasticity in the radial axis.
  • the prototypes were then subjected to a radial bias test simulating pressure of hemorrhoids on device. Pressure was applied to a sidewall of the prototypes and radial deformation was measured. This was effected in order to determine the radial pressure the prototypes can withstand without collapsing.
  • the benchmark pressure was set at 50 mmHg ( ⁇ 200 grams) which is slightly above the combination of the capillary (15 mmHg) and abdominal (30 mmHg) pressures. A deformation of no more than 5mm (radially) was considered a good result.
  • Table 1 summarizes device performance with respect to several functional parameters.
  • the present study demonstrated that the present device prototypes provide excellent anchoring with an anchoring force of ⁇ 1 kg or more, and a radial biasing force of 200 grams ( ⁇ 50 mmHg) with only 5 mm of deformation.
  • the stent-like braided tubular portion provided excellent radial elasticity without collapsing.
  • the prototype depicted in Figure 14 was used for in-vivo tests.
  • the device included an inflatable nylon balloon attached to a braided tubular body fabricated from polyester and coated with silicon.
  • the balloon was inflated to about 2-3 ATM.
  • Several balloon sizes (outer diameter) were tested - from 55 mm to 75 mm.
  • the tests were performed on a mature pig (weighting about 70 kg), with light anesthesia. The pig was very lightly sedated, the device was inserted and inflated and then the anesthesia was terminated and the porcine was released in its chamber ( Figures 15-16 ).
  • Tests showed that the insertion of the device (lubricated) was very easy and simple, that the anchoring of the device was excellent - the device was not pulled out spontaneously and remained in place for hours (until removed). The elasticity of the device was very good, enabling normal defecation through the device on several occasions.
  • the pig showed no signs of stress or discomfort during any stage of the tests, and its behavior was entirely normal - through eating, defecating and even sleeping.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nursing (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Claims (15)

  1. Dispositif (10) pour réduire la douleur, le saignement et/ou la distension d'hémorroïdes lors de la défécation et éventuellement lors de l'effort, comprenant un ballonnet (26) configuré pour être ancré à l'intérieur d'un bas rectum d'un sujet lorsqu'il est gonflé, caractérisé en ce que ledit ballonnet (26) est attaché à une structure maillée tubulaire (72) étant sensiblement non élastique le long d'un axe longitudinal et élastique le long d'un axe radial de celle-ci.
  2. Dispositif selon la revendication 1, dans lequel ladite structure maillée tubulaire est adaptée pour s'étendre depuis ledit bas rectum dans un canal anal lorsque ledit ballonnet est gonflé et ancré dans ledit bas rectum.
  3. Dispositif selon la revendication 1, dans lequel ladite structure maillée tubulaire est revêtue de silicone.
  4. Dispositif selon la revendication 1, dans lequel ladite structure maillée tubulaire est fabriquée à partir de polyester ou de nylon.
  5. Dispositif selon la revendication 1, dans lequel ladite structure maillée tubulaire est fabriquée à partir d'un matériau métallique choisi dans le groupe constitué d'acier inoxydable, de nitinol et de chrome-cobalt.
  6. Dispositif selon la revendication 1, dans lequel ledit ballonnet est un ballonnet toroïdal.
  7. Dispositif selon la revendication 6, dans lequel ledit ballonnet toroïdal inclut une ouverture de forme conique.
  8. Dispositif selon la revendication 1, dans lequel ledit ballonnet est un ballonnet non souple.
  9. Dispositif selon la revendication 1, comprenant en outre une gaine tubulaire pour retenir radialement ladite structure maillée tubulaire dans une configuration pliée.
  10. Dispositif selon la revendication 9, dans lequel ladite gaine tubulaire inclut un mécanisme pour libérer ladite structure maillée tubulaire de ladite configuration pliée.
  11. Dispositif selon la revendication 10, dans lequel ledit mécanisme déchire ou enlève ladite gaine.
  12. Système pour traiter la constipation lors de la défécation comprenant le dispositif selon la revendication 1 et un applicateur pour positionner et déployer ledit dispositif dans une région de canal anal-rectum d'un sujet.
  13. Système selon la revendication 12, dans lequel ledit applicateur inclut une lumière pour contenir le dispositif selon la revendication 1 dans une configuration pliée.
  14. Système selon la revendication 12, dans lequel ledit applicateur inclut un piston pour éjecter le dispositif selon la revendication 1 de ladite lumière.
  15. Système selon la revendication 12, dans lequel ledit applicateur se retire du dispositif lors du gonflement dudit ballonnet.
EP12779337.0A 2011-05-05 2012-04-30 Dispositif de protection d'hémorroïdes Not-in-force EP2704672B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161482659P 2011-05-05 2011-05-05
PCT/IL2012/050152 WO2012150597A1 (fr) 2011-05-05 2012-04-30 Dispositif de protection d'hémorroïdes

Publications (3)

Publication Number Publication Date
EP2704672A1 EP2704672A1 (fr) 2014-03-12
EP2704672A4 EP2704672A4 (fr) 2014-12-17
EP2704672B1 true EP2704672B1 (fr) 2016-02-10

Family

ID=47107805

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12779337.0A Not-in-force EP2704672B1 (fr) 2011-05-05 2012-04-30 Dispositif de protection d'hémorroïdes

Country Status (3)

Country Link
US (1) US9872788B2 (fr)
EP (1) EP2704672B1 (fr)
WO (1) WO2012150597A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9872788B2 (en) 2011-05-05 2018-01-23 Relief Therapies, Inc. Device for protecting hemorrhoids
US10166126B2 (en) 2014-12-08 2019-01-01 Boston Scientific Scimed, Inc. Inflatable balloon stent
EP4356915A3 (fr) * 2015-03-12 2024-07-17 Cristcot LLC Formulation de suppositoire à base d'acétate d'hydrocortisone pour le traitement d'une maladie
CN105498072B (zh) * 2016-01-19 2019-09-20 温州医科大学附属第二医院 一种肛周组织保护器
CN110584856A (zh) * 2019-10-15 2019-12-20 南京市中医院 一种肛托
US20210161701A1 (en) * 2019-11-09 2021-06-03 Airway Medix S.A. Bowel waste management systems and methods for use
WO2024194873A1 (fr) * 2023-03-23 2024-09-26 Anacure Medical Ltd Dispositif médical pour le traitement de troubles anorectaux

Family Cites Families (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US844450A (en) 1904-06-09 1907-02-19 Charles R Harris Rectal dilator.
US1527068A (en) 1923-09-13 1925-02-17 Albra C Parsons Instrument for treating piles
US2499045A (en) 1948-08-16 1950-02-28 Walker Frank Ray Rectal dilator and medicator
US3831583A (en) * 1971-03-05 1974-08-27 Univ California Implantable bulb for inflation of surgical implements
US3826242A (en) 1973-04-16 1974-07-30 P Eggers Method and apparatus for treatment of hemorrhoids
US4331151A (en) 1980-09-08 1982-05-25 Golden Theodore A Hemorrhoid bandage
US4341211A (en) 1981-09-08 1982-07-27 Kline Larry H Lubricating object applicator
US4686985A (en) * 1985-05-15 1987-08-18 Lottick Edward A Anal dilator and occluder
US4844073A (en) 1986-12-01 1989-07-04 Jerzy Pohler Device for treatment of hemorroids and rectal tissue after surgery treatment
US4932958A (en) 1988-05-10 1990-06-12 American Medical Systems, Inc. Prostate balloon dilator
US5263926A (en) 1992-02-18 1993-11-23 Wilk Peter J Device and related method for reducing swelling of hemorrhoidal tissues
US5456694A (en) 1994-05-13 1995-10-10 Stentco, Inc. Device for delivering and deploying intraluminal devices
GB2295551A (en) * 1994-11-30 1996-06-05 Richard John Heald Protective anal dilator
AU739710B2 (en) * 1996-08-23 2001-10-18 Boston Scientific Limited Stent delivery system having stent securement apparatus
US5924423A (en) 1997-04-22 1999-07-20 Heshmat Majlessi Device for reducing symptoms of prolapsed hemorrhoids
US5817124A (en) 1997-06-02 1998-10-06 Karell; Manuel L. Anal dilator with self-expanding element
US5941860A (en) 1997-11-03 1999-08-24 Wheeler; Alton D. Fecal pouch and installation
US6450989B2 (en) 1998-04-27 2002-09-17 Artemis Medical, Inc. Dilating and support apparatus with disease inhibitors and methods for use
US20010014821A1 (en) 1998-11-16 2001-08-16 Mohamad Ike Juman Balloon catheter and stent delivery system having enhanced stent retention
GB0007145D0 (en) 2000-03-24 2000-05-17 Beehive Device for anal pain relief
US6364852B1 (en) * 2000-08-17 2002-04-02 Sin Hang Lee Device for reduction of the anal cushions in the treatment of minor hemorrhoidal disease
US20020192273A1 (en) 2001-06-15 2002-12-19 Teri Buseman Therapeutic patch useful for the treatment of hemorrhoids
WO2004022150A1 (fr) 2002-08-23 2004-03-18 Japan As Represented By President Of National Cardiovascular Center Endoprothese et procede de production associe
US20040097866A1 (en) 2002-11-15 2004-05-20 Kyoto Kogyo Co., Ltd. Anal prolapse prevention aid
DE10305553B4 (de) * 2003-02-10 2005-11-03 Lothar Dr.med. Göbel Vorrichtung zur Tamponade von Körperhöhlen
AU2003292521A1 (en) * 2003-11-10 2005-05-26 Sapi Med S.P.A. Transanal device
US20050177213A1 (en) 2004-02-10 2005-08-11 Jerzy Pohler Disposable cryotherapy device for the treatment of hemorrhoids with frozen healing media
US8308789B2 (en) * 2004-07-16 2012-11-13 W. L. Gore & Associates, Inc. Deployment system for intraluminal devices
AT501766A1 (de) 2005-01-25 2006-11-15 Ami Gmbh Einrichtung zur verwendung bei der behandlung eines hämorrhoidenprolaps
EP1863405A2 (fr) * 2005-03-18 2007-12-12 Thomas D. Egan Systeme de fixation de prothese de derivation gastrique et methode de traitement de l'obesite
US8414633B2 (en) * 2005-07-21 2013-04-09 Cook Medical Technologies Llc Stent delivery system with a retention wire
DE102005053393A1 (de) * 2005-11-09 2007-05-10 Biotronik Vi Patent Ag Applikationssystem für einen Stent
US8678011B2 (en) * 2007-07-12 2014-03-25 Personics Holdings, Inc. Expandable earpiece sealing devices and methods
US20090043330A1 (en) * 2007-08-09 2009-02-12 Specialized Vascular Technologies, Inc. Embolic protection devices and methods
US8414501B2 (en) * 2007-12-28 2013-04-09 Medifocus, Inc. Thermal monitoring
EP2328525B1 (fr) * 2008-05-29 2018-11-07 Advanced Medical Balloons GmbH Dispositif de drainage des selles
WO2010020985A1 (fr) 2008-08-18 2010-02-25 Torus Medical Ltd Dispositif et méthode de manchon rectal gonflable
US9872788B2 (en) 2011-05-05 2018-01-23 Relief Therapies, Inc. Device for protecting hemorrhoids

Also Published As

Publication number Publication date
EP2704672A1 (fr) 2014-03-12
WO2012150597A1 (fr) 2012-11-08
US9872788B2 (en) 2018-01-23
US20140081311A1 (en) 2014-03-20
EP2704672A4 (fr) 2014-12-17

Similar Documents

Publication Publication Date Title
EP2704672B1 (fr) Dispositif de protection d'hémorroïdes
JP2999165B2 (ja) ステント供給装置
US20200170818A1 (en) Obesity treatment devices, systems, and methods
JP4824090B2 (ja) 骨盤底支持のための調節可能な膣副子
US8556988B2 (en) Apparatus and repair of defect in inguinal canal and other muscular structures
JP2023071970A (ja) 組織空洞内にシースを係留するためのデバイスおよび方法
US20070213661A1 (en) Closure system for managing rectal or anal incontinence
JP2019512326A5 (fr)
CN103735336A (zh) 用于改善女性尿失禁的装置
AU2009239658A1 (en) Duodenal liner device
KR20190003628A (ko) 비만 치료용 앵커리스 위내 장치
EP0720460A1 (fr) Bouchon uretral portant un adhesif lui conferant des capacites d'etancheite
CN102088927A (zh) 用于治疗腹主动脉瘤的装置和方法
JP2014518655A (ja) 肥満療法のためのシステムおよび方法
US20090149700A1 (en) Method and apparatus for pubic sling insertion
KR20190039715A (ko) 배액을 돕도록 구성된 동적 카테터 삽입 장치
US10226318B2 (en) Method of treating urinary incontinence by implanting a tube providing a pressure-regulating storage compartment
US20110066226A1 (en) Implantable Venous Valve for Treatment of Erectile Dysfunction
JP6778255B2 (ja) 経膣分娩中に骨盤底を保護する装置
US10799380B2 (en) Gastric device and method of use thereof
CN106580387B (zh) 医用体腔内部施压装置
EP2732799A1 (fr) Systèmes et procédés pour déployer un manchon endoluminale
CN106725685B (zh) 线控记忆伞

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20131205

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

A4 Supplementary search report drawn up and despatched

Effective date: 20141117

RIC1 Information provided on ipc code assigned before grant

Ipc: A61F 5/00 20060101ALI20141111BHEP

Ipc: A61F 5/442 20060101AFI20141111BHEP

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

INTG Intention to grant announced

Effective date: 20150923

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 774277

Country of ref document: AT

Kind code of ref document: T

Effective date: 20160215

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602012014740

Country of ref document: DE

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 5

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

REG Reference to a national code

Ref country code: NL

Ref legal event code: MP

Effective date: 20160210

REG Reference to a national code

Ref country code: AT

Ref legal event code: MK05

Ref document number: 774277

Country of ref document: AT

Kind code of ref document: T

Effective date: 20160210

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160510

Ref country code: IT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: ES

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160511

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160430

Ref country code: RS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160613

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160610

Ref country code: AT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602012014740

Country of ref document: DE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SM

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160430

Ref country code: BE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

26N No opposition filed

Effective date: 20161111

REG Reference to a national code

Ref country code: IE

Ref legal event code: MM4A

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160430

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160430

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160510

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 6

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160430

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 7

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO

Effective date: 20120430

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160430

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: MK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: AL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160210

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20190418

Year of fee payment: 8

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20190418

Year of fee payment: 8

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20190418

Year of fee payment: 8

REG Reference to a national code

Ref country code: DE

Ref legal event code: R119

Ref document number: 602012014740

Country of ref document: DE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20201103

Ref country code: FR

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200430

GBPC Gb: european patent ceased through non-payment of renewal fee

Effective date: 20200430

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20200430